510(k) · Cleared
ClearedLIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LSE Epstein-Barr Virus, Other
Cleared on Jan 5, 2017 as substantially equivalent to K040120 (DiaSorin, Inc., 2005) after a 73-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jan 5, 2017
- Review
- 73 days
- Class
- Class I
- Product code
- LSE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K946159 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK946159 Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa KitIncstar Corp. · 1995
- 1 generation backK040120 Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysDiaSorin, Inc. · 2005
- This deviceK162961 LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON®…DiaSorin, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K946159 | Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa Kit | Incstar Corp. | 1995 | — |
| −1 | K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays | DiaSorin, Inc. | 2005 | — |
| 0 (this device) | K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and… | DiaSorin, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LSE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LSE device
- #1 K233606 ADVIA Centaur EBV-VCA IgMscore 8.1 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysSummary page 5…6.3235; Class I, Microbiology(83) Product Code: LSE, JJX PREDICATE DEVICE: DiaSorin LIAISON® VCA IgG (K040120) DEVICE DESCRIPTION: The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer fam… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K040120.
How does its category compare?
All LSE devicesLSE Epstein-Barr Virus, Other: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LSE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LSE
Too few LSE 510(k)s in any year since 2007 to give a median.
Recalls per year · LSE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSE
1in 2014
MAUDE reports naming product code LSE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms…
Read the full statement (274 words)
The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBYV infection such as infectious mononucleosis.
The DiaSorin LIAISON® VCA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® VCA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® VCA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL).
The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis.
The DiaSorin LIAISON® EBNA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBNA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EBNA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162961: LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162961
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026